|Publication number||US7972378 B2|
|Application number||US 12/321,760|
|Publication date||5 Jul 2011|
|Filing date||23 Jan 2009|
|Priority date||24 Jan 2008|
|Also published as||CA2714062A1, EP2254514A2, US8673000, US20090287299, US20110224780, US20140142694, WO2009094188A2, WO2009094188A3|
|Publication number||12321760, 321760, US 7972378 B2, US 7972378B2, US-B2-7972378, US7972378 B2, US7972378B2|
|Inventors||Charles Tabor, Carol E. Eberhardt, Timothy G. Laske, Timothy R. Ryan, Joseph C. Morrow, Tammy Y. Tam, Brian A. Glynn, Anne L. Brody Rubin, J. Michael Tuchek|
|Original Assignee||Medtronic, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (114), Non-Patent Citations (44), Referenced by (13), Classifications (23), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present application claims priority to U.S. Provisional Application Nos. 61/062,207, filed Jan. 24, 2008, and titled “Delivery Systems and Methods of Implantation for Prosthetic Heart Valves”; and 61/075,902, filed Jun. 26, 2008 and titled “Heart Valve”; the entire contents of which are incorporated herein by reference in their entireties.
The present invention relates to prosthetic heart valves. More particularly, it relates to devices, methods, and delivery systems for percutaneously implanting prosthetic heart valves.
Diseased or otherwise deficient heart valves can be repaired or replaced using a variety of different types of heart valve surgeries. Typical heart valve surgeries involve an open-heart surgical procedure that is conducted under general anesthesia, during which the heart is stopped while blood flow is controlled by a heart-lung bypass machine. This type of valve surgery is highly invasive and exposes the patient to a number of potentially serious risks, such as infection, stroke, renal failure, and adverse effects associated with use of the heart-lung machine, for example.
Recently, there has been increasing interest in minimally invasive and percutaneous replacement of cardiac valves. Such surgical techniques involve making a very small opening in the skin of the patient into which a valve assembly is inserted in the body and delivered to the heart via a delivery device similar to a catheter. This technique is often preferable to more invasive forms of surgery, such as the open-heart surgical procedure described above. In the context of pulmonary valve replacement, U.S. Patent Application Publication Nos. 2003/0199971 A1 and 2003/0199963 A1, both filed by Tower, et al., describe a valved segment of bovine jugular vein, mounted within an expandable stent, for use as a replacement pulmonary valve. The replacement valve is mounted on a balloon catheter and delivered percutaneously via the vascular system to the location of the failed pulmonary valve and expanded by the balloon to compress the valve leaflets against the right ventricular outflow tract, anchoring and sealing the replacement valve. As described in the articles: “Percutaneous Insertion of the Pulmonary Valve”, Bonhoeffer, et al., Journal of the American College of Cardiology 2002; 39: 1664-1669 and “Transcatheter Replacement of a Bovine Valve in Pulmonary Position”, Bonhoeffer, et al., Circulation 2000; 102: 813-816, the replacement pulmonary valve may be implanted to replace native pulmonary valves or prosthetic pulmonary valves located in valved conduits.
Various types and configurations of prosthetic heart valves are used in percutaneous valve procedures to replace diseased natural human heart valves. The actual shape and configuration of any particular prosthetic heart valve is dependent to some extent upon the valve being replaced (i.e., mitral valve, tricuspid valve, aortic valve, or pulmonary valve). In general, the prosthetic heart valve designs attempt to replicate the function of the valve being replaced and thus will include valve leaflet-like structures used with either bioprostheses or mechanical heart valve prostheses. In other words, the replacement valves may include a valved vein segment that is mounted in some manner within an expandable stent to make a stented valve. In order to prepare such a valve for percutaneous implantation, the stented valve can be initially provided in an expanded or uncrimped condition, then crimped or compressed around the balloon portion of a catheter until it is as close to the diameter of the catheter as possible.
Other percutaneously-delivered prosthetic heart valves have been suggested having a generally similar configuration, such as by Bonhoeffer, P. et al., “Transcatheter Implantation of a Bovine Valve in Pulmonary Position.” Circulation, 2002; 102:813-816, and by Cribier, A. et al. “Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis.” Circulation, 2002; 106:3006-3008, the disclosures of which are incorporated herein by reference. These techniques rely at least partially upon a frictional type of engagement between the expanded support structure and the native tissue to maintain a position of the delivered prosthesis, although the stents can also become at least partially embedded in the surrounding tissue in response to the radial force provided by the stent and balloons used to expand the stent. Thus, with these transcatheter techniques, conventional sewing of the prosthetic heart valve to the patient's native tissue is not necessary. Similarly, in an article by Bonhoeffer, P. et al. titled “Percutaneous Insertion of the Pulmonary Valve.” J Am Coll Cardiol, 2002; 39:1664-1669, the disclosure of which is incorporated herein by reference, percutaneous delivery of a biological valve is described. The valve is sutured to an expandable stent within a previously implanted valved or non-valved conduit, or a previously implanted valve. Again, radial expansion of the secondary valve stent is used for placing and maintaining the replacement valve.
Although there have been advances in percutaneous valve replacement techniques and devices, there is a continued desire to provide different designs of cardiac valves that can be implanted in a minimally invasive and percutaneous manner. It is additionally desirable to provide valves that are resistant to migration after they are implanted.
The replacement heart valves of the invention each include a stent to which a valve structure is attached. The stents of the invention include a wide variety of structures and features that can be used alone or in combination with features of other stents of the invention. Many of the structures are compressible to a relatively small diameter for percutaneous delivery to the heart of the patient, and then are expandable either via removal of external compressive forces (e.g., self-expanding stents), or through application of an outward radial force (e.g., balloon expandable stents). The devices delivered by the delivery systems described herein can be used to deliver stents, valved stents, or other interventional devices such as ASD (atrial septal defect) closure devices, VSD (ventricular septal defect) closure devices, or PFO (patent foramen ovale) occluders.
Methods for insertion of the replacement heart valves of the invention include delivery systems that can maintain the stent structures in their compressed state during their insertion and allow or cause the stent structures to expand once they are in their desired location. In addition, delivery methods of the invention can include features that allow the stents to be retrieved for removal or relocation thereof after they have been deployed or partially deployed from the stent delivery systems. The methods may include implantation of the stent structures using either an antegrade or retrograde approach. Further, in many of the delivery approaches of the invention, the stent structure is rotatable in vivo to allow the stent structure to be positioned in a desired orientation.
The stent structures of the invention can provide resistance to leaflet abrasion via the configuration of the wires or other structural elements relative to each other. Other stent structures can provide for reduced crown density and various other configurations of wire shapes and features for use with attached valves for valve replacement procedures.
The present invention will be further explained with reference to the appended Figures, wherein like structure is referred to by like numerals throughout the several views, and wherein:
As referred to herein, the prosthetic heart valves used in accordance with various devices and methods of heart valve delivery may include a wide variety of different configurations, such as a prosthetic heart valve having tissue leaflets or a synthetic heart valve having polymeric, metallic, or tissue-engineered leaflets, and can be specifically configured for replacing any heart valve. That is, while much of the description herein refers to replacement of aortic valves, the prosthetic heart valves of the invention can also generally be used for replacement of native mitral, pulmonic, or tricuspid valves, for use as a venous valve, or to replace a failed bioprosthesis, such as in the area of an aortic valve or mitral valve, for example.
Although each of the valves used with the delivery devices and methods described herein would typically include leaflets attached within an interior area of a stent, the leaflets are not shown in many of the illustrated embodiments for clarity purposes. In general, the stents described herein include a support structure comprising a number of strut or wire portions arranged relative to each other to provide a desired compressibility, strength, and leaflet attachment zone(s) to the heart valve. Other details on particular configurations of the stents of the invention are also described below; however, in general terms, stents of the invention are generally tubular support structures, and leaflets will be secured to the support structure to provide a valved stent. The leaflets can be formed from a variety of materials, such as autologous tissue, xenograph material, or synthetics as are known in the art. The leaflets may be provided as a homogenous, biological valve structure, such as a porcine, bovine, or equine valve. Alternatively, the leaflets can be provided independent of one another (e.g., bovine or equine pericardial leaflets) and subsequently assembled to the support structure of the stent. In another alternative, the stent and leaflets can be fabricated at the same time, such as may be accomplished using high strength nano-manufactured NiTi films of the type produced at Advanced Bio Prosthetic Surfaces Ltd. (ABPS) of San Antonio, Tex., for example. The support structures are generally configured to accommodate three leaflets; however, the replacement prosthetic heart valves of the invention can incorporate more or less than three leaflets.
In more general terms, the combination of a support structure with one or more leaflets can assume a variety of other configurations that differ from those shown and described, including any known prosthetic heart valve design. In certain embodiments of the invention, the support structure with leaflets utilize certain features of known expandable prosthetic heart valve configurations, whether balloon expandable, self-expanding, or unfurling (as described, for example, in U.S. Pat. Nos. 3,671,979; 4,056,854; 4,994,077; 5,332,402; 5,370,685; 5,397,351; 5,554,185; 5,855,601; and 6,168,614; U.S. Patent Application Publication No. 2004/0034411; Bonhoeffer P., et al., “Percutaneous Insertion of the Pulmonary Valve”, Pediatric Cardiology, 2002; 39:1664-1669; Anderson H R, et al., “Transluminal Implantation of Artificial Heart Valves”, EUR Heart J., 1992; 13:704-708; Anderson, J. R., et al., “Transluminal Catheter Implantation of New Expandable Artificial Cardiac Valve”, EUR Heart J., 1990, 11: (Suppl) 224a; Hilbert S. L., “Evaluation of Explanted Polyurethane Trileaflet Cardiac Valve Prosthesis”, J Thorac Cardiovascular Surgery, 1989; 94:419-29; Block P C, “Clinical and Hemodyamic Follow-Up After Percutaneous Aortic Valvuloplasty in the Elderly”, The American Journal of Cardiology, Vol. 62, Oct. 1, 1998; Boudjemline, Y., “Steps Toward Percutaneous Aortic Valve Replacement”, Circulation, 2002; 105:775-558; Bonhoeffer, P., “Transcatheter Implantation of a Bovine Valve in Pulmonary Position, a Lamb Study”, Circulation, 2000: 102:813-816; Boudjemline, Y., “Percutaneous Implantation of a Valve in the Descending Aorta In Lambs”, EUR Heart J, 2002; 23:1045-1049; Kulkinski, D., “Future Horizons in Surgical Aortic Valve Replacement: Lessons Learned During the Early Stages of Developing a Transluminal Implantation Technique”, ASAIO J, 2004; 50:364-68; the teachings of which are all incorporated herein by reference).
Orientation and positioning of the stents of the invention may be accomplished either by self-orientation of the stents (such as by interference between features of the stent and a previously implanted stent or valve structure) or by manual orientation of the stent to align its features with anatomical or previous bioprosthetic features, such as can be accomplished using fluoroscopic visualization techniques, for example. For example, when aligning the stents of the invention with native anatomical structures, they should be aligned so as to not block the coronary arteries, and native mitral or tricuspid valves should be aligned relative to the anterior leaflet and/or the trigones/commissures.
Some embodiments of the support structures of the stents described herein can be a series of wires or wire segments arranged so that they are capable of transitioning from a collapsed state to an expanded state. In some embodiments, a number of individual wires comprising the support structure can be formed of a metal or other material. These wires are arranged in such a way that a support structure allows for folding or compressing to a contracted state in which its internal diameter is greatly reduced from its internal diameter in an expanded state. In its collapsed state, such a support structure with attached valves can be mounted over a delivery device, such as a balloon catheter, for example. The support structure is configured so that it can be changed to its expanded state when desired, such as by the expansion of a balloon catheter. The delivery systems used for such a stent should be provided with degrees of rotational and axial orientation capabilities in order to properly position the new stent at its desired location.
The wires of the support structure of the stents in other embodiments can alternatively be formed from a shape memory material such as a nickel titanium alloy (e.g., Nitinol) or a very high-tensile material that will expand to its original state after compression and removal of external forces. With this material, the support structure is self-expandable from a contracted state to an expanded state, such as by the application of heat, energy, and the like, or by the removal of external forces (e.g., compressive forces). This support structure can be repeatedly compressed and re-expanded without damaging the structure of the stent. In addition, the support structure of such an embodiment may be laser cut from a single piece of material or may be assembled from a number of different components. For these types of stent structures, one example of a delivery system that can be used includes a catheter with a retractable sheath that covers the stent until it is to be deployed, at which point the sheath can be retracted to allow the stent to expand. Alternatively, the stent structures of the invention can be implanted using conventional surgical techniques and/or minimally invasive surgical procedures. In such cases, the stents of the invention can advantageously require relatively few or no sutures to secure the stent to an anatomical location within the patient.
Referring now to the Figures, wherein the components are labeled with like numerals throughout the several Figures, and initially to
With this stent 10, wire structure extends between one end of the post 16 and the first end 12 (which may be referred to as the aortic aspect of the stent) and additional wire structure extends between the other end of the stent post and the second end 14 (which may be referred to as the ventricular aspect of the stent). The stent 10 may include one longitudinal post 16 for each commissure of the valve that will be attached thereto, if desired. That is, for a three-leaflet valve, three longitudinal posts 16 will be provided.
The stent 20 of
Reduction of the potential wear on the valve leaflets can alternatively be accomplished by fastening leaflet commissures closer to the center of the stent than to the outer circumference.
Stents 10, 20, and 40 each include an arrangement of wires that provides twelve stent crowns at one end and six stent crowns at the opposite end, while stent 30 includes twelve crowns at both ends. For embodiments that include twelve crowns at the inflow end of the stent, this configuration can provide additional strength to the stent annulus area to prevent migration, to open stenotic native valve orifices, and also to provide a greater number of points for attaching pericardial leaflets to the stent. It is possible, however, to provide less than twelve (e.g., six) crowns at the outflow because the same stent strength is not required at this end for less tissue attachment points are needed. These illustrated stents are only some of the arrangements of wires that can achieve this feature of having different numbers of stent crowns at opposite ends of a single stent. In a further alternative, each of the ends of one stent can have the same number of stent crowns, but the center portion can have a more or less dense concentration of wires than either of the ends. In any case, a stent having less stent crowns at one of its ends may simplify the use of an associated delivery system, since the end with less stent crowns will have a corresponding smaller number of crowns that need to be connected to the delivery system.
The outer profile of stent 180 is shown in an exemplary position within the anatomy (i.e., aorta) of a patient in
It is noted that in many of the stent embodiments shown and described herein, the aspect ratio of certain portions of the stent is exemplary, and can be somewhat different from that shown. It is further noted that if the stent of any of the embodiments is to be positioned to replace the aortic valve, the stent can be provided with a lower density wire portion in the area where the coronaries are located. To eliminate the need to clock the device, reduced wire density around the entire perimeter of the stent in the central area can be provided. Further, stent embodiments described herein may be modified to include additional structure for attachment of tissue for the valve, such as the vertical stent posts described in many of the embodiments.
One exemplary stent of the invention combines the following features: eyelets at one end for attachment to the delivery system and tissue valve; vertical commissural tissue attach struts or posts; moderately flared non-commissural attach vertical struts or STJ flare; sub-annular flares; inflow and outflow atraumatic curvatures; a twelve crown inflow; and six tapered crowns at the outflow end. Such an embodiment of a stent is illustrated, for example, as stent 250 in
Delivering any balloon-expandable stents of the invention to the implantation location can be performed percutaneously. In general terms, this includes providing a transcatheter assembly, including a delivery catheter, a balloon catheter, and a guide wire. Some delivery catheters of this type are known in the art, and define a lumen within which the balloon catheter is received. The balloon catheter, in turn, defines a lumen within which the guide wire is slideably disposed. Further, the balloon catheter includes a balloon that is fluidly connected to an inflation source. It is noted that if the stent being implanted is the self-expanding type of stent, the balloon would not be needed and a sheath or other restraining means would be used for maintaining the stent in its compressed state until deployment of the stent, as described herein. In any case, for a balloon-expandable stent, the transcatheter assembly is appropriately sized for a desired percutaneous approach to the implantation location. For example, the transcatheter assembly can be sized for delivery to the heart valve via an opening at a carotid artery, a jugular vein, a sub-clavian vein, femoral artery or vein, or the like. Essentially, any percutaneous intercostals penetration can be made to facilitate use of the transcatheter assembly.
Prior to delivery, the stent is mounted over the balloon in a contracted state to be as small as possible without causing permanent deformation of the stent structure. As compared to the expanded state, the support structure is compressed onto itself and the balloon, thus defining a decreased inner diameter as compared to an inner diameter in the expanded state. While this description is related to the delivery of a balloon-expandable stent, the same basic procedures can also be applicable to a self-expanding stent, where the delivery system would not include a balloon, but would preferably include a sheath or some other type of configuration for maintaining the stent in a compressed condition until its deployment.
With the stent mounted to the balloon, the transcatheter assembly is delivered through a percutaneous opening (not shown) in the patient via the delivery catheter. The implantation location is located by inserting the guide wire into the patient, which guide wire extends from a distal end of the delivery catheter, with the balloon catheter otherwise retracted within the delivery catheter. The balloon catheter is then advanced distally from the delivery catheter along the guide wire, with the balloon and stent positioned relative to the implantation location. In an alternative embodiment, the stent is delivered to an implantation location via a minimally invasive surgical incision (i.e., non-percutaneously). In another alternative embodiment, the stent is delivered via open heart/chest surgery. In one embodiment of the stents of the invention, the stent includes a radiopaque, echogenic, or MRI visible material to facilitate visual confirmation of proper placement of the stent. Alternatively, other known surgical visual aids can be incorporated into the stent. The techniques described relative to placement of the stent within the heart can be used both to monitor and correct the placement of the stent in a longitudinal direction relative to the length of the anatomical structure in which it is positioned.
Once the stent is properly positioned, the balloon catheter is operated to inflate the balloon, thus transitioning the stent to an expanded state. Alternatively, where the support structure is formed of a shape memory material, the stent can self-expand to its expanded state.
One or more markers on the valve, along with a corresponding imaging system (e.g., echo, MRI, etc.) can be used with the various repositionable delivery systems described herein in order to verify the proper placement of the valve prior to releasing it from the delivery system. A number of factors can be considered, alone or in combination, to verify that the valve is properly placed in an implantation site, where some exemplary factors are as follows: (1) lack of paravalvular leakage around the replacement valve, which can be advantageously examined while blood is flowing through the valve since these delivery systems allow for flow through and around the valve; (2) optimal rotational orientation of the replacement valve relative to the coronary arteries; (3) the presence of coronary flow with the replacement valve in place; (4) correct longitudinal alignment of the replacement valve annulus with respect to the native patient anatomy; (5) verification that the position of the sinus region of the replacement valve does not interfere with native coronary flow; (6) verification that the sealing skirt is aligned with anatomical features to minimize paravalvular leakage; (7) verification that the replacement valve does not induce arrhythmias prior to final release; and (8) verification that the replacement valve does not interfere with function of an adjacent valve, such as the mitral valve.
This stent assembly 280 can include flexible connections between annular and supra-annular stent aspects. The flexible connections may be elastomeric, fabric, metal, or the like. Such flexible connections can help the stent assembly to accommodate most varying anatomy above the sinotubular junction and also to accommodate aortic curvature. In addition, the flexible connections can make the stent assembly able to accommodate anerysmal aortas.
The stent assembly 280 may further include a gasket 294 positioned adjacent an end of the stented valve 282. In addition, when the stent assembly is implanted in a patient, a plaque pocket 296 can be created that provides embolic protection by creating a volume that can entrap plaque, calcification, and other emboli from traveling in a distal direction and causing a thromembolic event, such as a stroke.
Alternatively, portions of the system may be designed to include a longer useful life than others. For example, the frame of the present invention could be designed to have a relatively long useful life (e.g. 20 years), while the tissue component could have a relatively shorter useful life (e.g. 10 years).
An embolic protection device 292 can be provided distal to the stent assembly 280, as is shown in
Several stents of the present invention can alleviate this non-conformity of the valve frame with the native anatomy. In one embodiment, the stent could have a predetermined curvature that matches or more closely conforms to the native anatomy, such as stent 335 in
The present invention also optionally or alternatively includes distal emoboli protection features which may be incorporated into a delivery system for delivering a stent assembly (e.g. in the nose assembly), such as the thromboembolic filter. The protection features may provide acute protection during percutaneous valve delivery. The protection features may afford substantially uninhibited flow through coronaries during systole or diastole.
The present invention has now been described with reference to several embodiments thereof. The entire disclosure of any patent or patent application identified herein is hereby incorporated by reference. The foregoing detailed description and examples have been given for clarity of understanding only. No unnecessary limitations are to be understood therefrom. It will be apparent to those skilled in the art that many changes can be made in the embodiments described without departing from the scope of the invention. Thus, the scope of the present invention should not be limited to the structures described herein, but only by the structures described by the language of the claims and the equivalents of those structures.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US3334629||9 Nov 1964||8 Aug 1967||Bertram D Cohn||Occlusive device for inferior vena cava|
|US3409013||23 Oct 1965||5 Nov 1968||Berry Henry||Instrument for inserting artificial heart valves|
|US3540431||4 Apr 1968||17 Nov 1970||Kazi Mobin Uddin||Collapsible filter for fluid flowing in closed passageway|
|US3587115||1 Dec 1967||28 Jun 1971||Shiley Donald P||Prosthetic sutureless heart valves and implant tools therefor|
|US3628535||12 Nov 1969||21 Dec 1971||Nibot Corp||Surgical instrument for implanting a prosthetic heart valve or the like|
|US3642004||5 Jan 1970||15 Feb 1972||Life Support Equipment Corp||Urethral valve|
|US3657744||8 May 1970||25 Apr 1972||Univ Minnesota||Method for fixing prosthetic implants in a living body|
|US3671979||23 Sep 1969||27 Jun 1972||Univ Utah||Catheter mounted artificial heart valve for implanting in close proximity to a defective natural heart valve|
|US3714671||30 Nov 1970||6 Feb 1973||Cutter Lab||Tissue-type heart valve with a graft support ring or stent|
|US3755823||23 Apr 1971||4 Sep 1973||Hancock Laboratories Inc||Flexible stent for heart valve|
|US3795246||26 Jan 1973||5 Mar 1974||Bard Inc C R||Venocclusion device|
|US3839741||17 Nov 1972||8 Oct 1974||Haller J||Heart valve and retaining means therefor|
|US3868956||5 Jun 1972||4 Mar 1975||Ralph J Alfidi||Vessel implantable appliance and method of implanting it|
|US3874388||12 Feb 1973||1 Apr 1975||Ochsner Med Found Alton||Shunt defect closure system|
|US4035849||25 Jun 1976||19 Jul 1977||William W. Angell||Heart valve stent and process for preparing a stented heart valve prosthesis|
|US4056854||28 Sep 1976||8 Nov 1977||The United States Of America As Represented By The Department Of Health, Education And Welfare||Aortic heart valve catheter|
|US4106129||26 Aug 1977||15 Aug 1978||American Hospital Supply Corporation||Supported bioprosthetic heart valve with compliant orifice ring|
|US4222126||14 Dec 1978||16 Sep 1980||The United States Of America As Represented By The Secretary Of The Department Of Health, Education & Welfare||Unitized three leaflet heart valve|
|US4233690||19 May 1978||18 Nov 1980||Carbomedics, Inc.||Prosthetic device couplings|
|US4265694||22 Jan 1980||5 May 1981||The United States Of America As Represented By The Department Of Health, Education And Welfare||Method of making unitized three leaflet heart valve|
|US4291420||13 Jun 1980||29 Sep 1981||Medac Gesellschaft Fur Klinische Spezialpraparate Mbh||Artificial heart valve|
|US4297749||27 Feb 1980||3 Nov 1981||Albany International Corp.||Heart valve prosthesis|
|US4339831||27 Mar 1981||20 Jul 1982||Medtronic, Inc.||Dynamic annulus heart valve and reconstruction ring|
|US4343048||4 Aug 1980||10 Aug 1982||Ross Donald N||Stent for a cardiac valve|
|US4345340||7 May 1981||24 Aug 1982||Vascor, Inc.||Stent for mitral/tricuspid heart valve|
|US4425908||22 Oct 1981||17 Jan 1984||Beth Israel Hospital||Blood clot filter|
|US4470157||19 Apr 1983||11 Sep 1984||Love Jack W||Tricuspid prosthetic tissue heart valve|
|US4501030||17 Aug 1981||26 Feb 1985||American Hospital Supply Corporation||Method of leaflet attachment for prosthetic heart valves|
|US4506394||13 Jan 1983||26 Mar 1985||Molrose Management, Ltd.||Cardiac valve prosthesis holder|
|US4574803||17 Feb 1981||11 Mar 1986||Karl Storz||Tissue cutter|
|US4580568||1 Oct 1984||8 Apr 1986||Cook, Incorporated||Percutaneous endovascular stent and method for insertion thereof|
|US4592340||2 May 1984||3 Jun 1986||Boyles Paul W||Artificial catheter means|
|US4610688||4 Apr 1983||9 Sep 1986||Pfizer Hospital Products Group, Inc.||Triaxially-braided fabric prosthesis|
|US4612011||22 Jul 1983||16 Sep 1986||Hans Kautzky||Central occluder semi-biological heart valve|
|US4647283||13 Nov 1984||3 Mar 1987||American Hospital Supply Corporation||Implantable biological tissue and process for preparation thereof|
|US4648881||29 Nov 1982||10 Mar 1987||American Hospital Supply Corporation||Implantable biological tissue and process for preparation thereof|
|US4655771||11 Apr 1983||7 Apr 1987||Shepherd Patents S.A.||Prosthesis comprising an expansible or contractile tubular body|
|US4662885||3 Sep 1985||5 May 1987||Becton, Dickinson And Company||Percutaneously deliverable intravascular filter prosthesis|
|US4665906||21 May 1986||19 May 1987||Raychem Corporation||Medical devices incorporating sim alloy elements|
|US4681908||31 Oct 1985||21 Jul 1987||Dow Corning Corporation||Hard organopolysiloxane release coating|
|US4710192||17 Oct 1986||1 Dec 1987||Liotta Domingo S||Diaphragm and method for occlusion of the descending thoracic aorta|
|US4733665||7 Nov 1985||29 Mar 1988||Expandable Grafts Partnership||Expandable intraluminal graft, and method and apparatus for implanting an expandable intraluminal graft|
|US4777951||19 Sep 1986||18 Oct 1988||Mansfield Scientific, Inc.||Procedure and catheter instrument for treating patients for aortic stenosis|
|US4787899||10 Dec 1986||29 Nov 1988||Lazarus Harrison M||Intraluminal graft device, system and method|
|US4796629||3 Jun 1987||10 Jan 1989||Joseph Grayzel||Stiffened dilation balloon catheter device|
|US4797901||22 Aug 1986||10 Jan 1989||Siemens Aktiengesellschaft||Circuit arrangement for testing a passive bus network with the carrier sense multiple access with collisions detection method|
|US4819751||16 Oct 1987||11 Apr 1989||Baxter Travenol Laboratories, Inc.||Valvuloplasty catheter and method|
|US4834755||4 Mar 1985||30 May 1989||Pfizer Hospital Products Group, Inc.||Triaxially-braided fabric prosthesis|
|US4856516||9 Jan 1989||15 Aug 1989||Cordis Corporation||Endovascular stent apparatus and method|
|US4872874||29 May 1987||10 Oct 1989||Taheri Syde A||Method and apparatus for transarterial aortic graft insertion and implantation|
|US4878495||15 May 1987||7 Nov 1989||Joseph Grayzel||Valvuloplasty device with satellite expansion means|
|US4878906||6 Jun 1988||7 Nov 1989||Servetus Partnership||Endoprosthesis for repairing a damaged vessel|
|US4883458||13 Jun 1988||28 Nov 1989||Surgical Systems & Instruments, Inc.||Atherectomy system and method of using the same|
|US4909252||26 May 1988||20 Mar 1990||The Regents Of The Univ. Of California||Perfusion balloon catheter|
|US4917102||14 Sep 1988||17 Apr 1990||Advanced Cardiovascular Systems, Inc.||Guidewire assembly with steerable adjustable tip|
|US4922905||28 May 1987||8 May 1990||Strecker Ernst P||Dilatation catheter|
|US4954126||28 Mar 1989||4 Sep 1990||Shepherd Patents S.A.||Prosthesis comprising an expansible or contractile tubular body|
|US4966604||23 Jan 1989||30 Oct 1990||Interventional Technologies Inc.||Expandable atherectomy cutter with flexibly bowed blades|
|US4979939||12 May 1989||25 Dec 1990||Surgical Systems & Instruments, Inc.||Atherectomy system with a guide wire|
|US4986830||22 Sep 1989||22 Jan 1991||Schneider (U.S.A.) Inc.||Valvuloplasty catheter with balloon which remains stable during inflation|
|US4994077||21 Apr 1989||19 Feb 1991||Dobben Richard L||Artificial heart valve for implantation in a blood vessel|
|US5002559||30 Nov 1989||26 Mar 1991||Numed||PTCA catheter|
|US5007896||16 Mar 1989||16 Apr 1991||Surgical Systems & Instruments, Inc.||Rotary-catheter for atherectomy|
|US5026366||2 Dec 1986||25 Jun 1991||Cardiovascular Laser Systems, Inc.||Angioplasty catheter and method of use thereof|
|US5032128||7 Jul 1988||16 Jul 1991||Medtronic, Inc.||Heart valve prosthesis|
|US5037434||11 Apr 1990||6 Aug 1991||Carbomedics, Inc.||Bioprosthetic heart valve with elastic commissures|
|US5047041||23 Mar 1990||10 Sep 1991||Samuels Peter B||Surgical apparatus for the excision of vein valves in situ|
|US5059177||19 Apr 1990||22 Oct 1991||Cordis Corporation||Triple lumen balloon catheter|
|US5061273||5 Jul 1990||29 Oct 1991||Yock Paul G||Angioplasty apparatus facilitating rapid exchanges|
|US5085635||18 May 1990||4 Feb 1992||Cragg Andrew H||Valved-tip angiographic catheter|
|US5089015||28 Nov 1989||18 Feb 1992||Promedica International||Method for implanting unstented xenografts and allografts|
|US5152771||31 Dec 1990||6 Oct 1992||The Board Of Supervisors Of Louisiana State University||Valve cutter for arterial by-pass surgery|
|US5161547||28 Nov 1990||10 Nov 1992||Numed, Inc.||Method of forming an intravascular radially expandable stent|
|US5163953||10 Feb 1992||17 Nov 1992||Vince Dennis J||Toroidal artificial heart valve stent|
|US5167628||2 May 1991||1 Dec 1992||Boyles Paul W||Aortic balloon catheter assembly for indirect infusion of the coronary arteries|
|US5217483||15 May 1992||8 Jun 1993||Numed, Inc.||Intravascular radially expandable stent|
|US5232445||9 Oct 1991||3 Aug 1993||Tassilo Bonzel||Dilatation catheter|
|US5272909||25 Apr 1991||28 Dec 1993||Baxter International Inc.||Method and device for testing venous valves|
|US5295958||4 Apr 1991||22 Mar 1994||Shturman Cardiology Systems, Inc.||Method and apparatus for in vivo heart valve decalcification|
|US5327774||8 Oct 1993||12 Jul 1994||Baxter International Inc.||Method for testing venous valves|
|US5332402||12 May 1992||26 Jul 1994||Teitelbaum George P||Percutaneously-inserted cardiac valve|
|US5350398||28 May 1993||27 Sep 1994||Dusan Pavcnik||Self-expanding filter for percutaneous insertion|
|US5370685||16 Jul 1991||6 Dec 1994||Stanford Surgical Technologies, Inc.||Endovascular aortic valve replacement|
|US5389106||29 Oct 1993||14 Feb 1995||Numed, Inc.||Impermeable expandable intravascular stent|
|US5397351||13 May 1991||14 Mar 1995||Pavcnik; Dusan||Prosthetic valve for percutaneous insertion|
|US5411552||14 Jun 1994||2 May 1995||Andersen; Henning R.||Valve prothesis for implantation in the body and a catheter for implanting such valve prothesis|
|US5415633||28 Jul 1993||16 May 1995||Active Control Experts, Inc.||Remotely steered catheterization device|
|US5431676||5 Mar 1993||11 Jul 1995||Innerdyne Medical, Inc.||Trocar system having expandable port|
|US5443446||3 Feb 1994||22 Aug 1995||Shturman Cardiology Systems, Inc.||Method and apparatus for in vivo heart valve decalcification|
|US5449384||28 Sep 1992||12 Sep 1995||Medtronic, Inc.||Dynamic annulus heart valve employing preserved porcine valve leaflets|
|US5480424||1 Nov 1993||2 Jan 1996||Cox; James L.||Heart valve replacement using flexible tubes|
|US5489294||1 Feb 1994||6 Feb 1996||Medtronic, Inc.||Steroid eluting stitch-in chronic cardiac lead|
|US5489297||2 Nov 1994||6 Feb 1996||Duran; Carlos M. G.||Bioprosthetic heart valve with absorbable stent|
|US5496346||25 May 1993||5 Mar 1996||Advanced Cardiovascular Systems, Inc.||Reinforced balloon dilatation catheter with slitted exchange sleeve and method|
|US5500014||9 May 1994||19 Mar 1996||Baxter International Inc.||Biological valvular prothesis|
|US5507767||15 Jan 1992||16 Apr 1996||Cook Incorporated||Spiral stent|
|US5545209||30 Jun 1994||13 Aug 1996||Texas Petrodet, Inc.||Controlled deployment of a medical device|
|US5545211||22 Sep 1994||13 Aug 1996||Sooho Medi-Tech Co., Ltd.||Stent for expanding a lumen|
|US5545214||4 Mar 1994||13 Aug 1996||Heartport, Inc.||Endovascular aortic valve replacement|
|US6299637 *||20 Aug 1999||9 Oct 2001||Samuel M. Shaolian||Transluminally implantable venous valve|
|US7351256 *||28 Mar 2003||1 Apr 2008||Cordis Corporation||Frame based unidirectional flow prosthetic implant|
|US7547322 *||29 Jun 2004||16 Jun 2009||The Cleveland Clinic Foundation||Prosthetic valve and method for making same|
|US7569071 *||21 Sep 2005||4 Aug 2009||Boston Scientific Scimed, Inc.||Venous valve, system, and method with sinus pocket|
|US7618447 *||30 Aug 2004||17 Nov 2009||Cook Incorporated||Artificial valve prosthesis with improved flow dynamics|
|US20020032481 *||9 Oct 2001||14 Mar 2002||Shlomo Gabbay||Heart valve prosthesis and sutureless implantation of a heart valve prosthesis|
|US20030199975 *||9 Aug 2002||23 Oct 2003||Shlomo Gabbay||Low invasive implantable cardiac prosthesis and method for helping improve operation of a heart valve|
|US20070043435 *||15 May 2006||22 Feb 2007||Jacques Seguin||Non-cylindrical prosthetic valve system for transluminal delivery|
|US20070078510 *||26 Sep 2006||5 Apr 2007||Ryan Timothy R||Prosthetic cardiac and venous valves|
|US20070142907 *||14 Dec 2006||21 Jun 2007||Micardia Corporation||Adjustable prosthetic valve implant|
|US20070213813 *||21 Dec 2006||13 Sep 2007||Symetis Sa||Stent-valves for valve replacement and associated methods and systems for surgery|
|US20070288087 *||30 May 2007||13 Dec 2007||Cook Incorporated||Artificial valve prosthesis|
|US20090005863 *||15 Aug 2008||1 Jan 2009||Goetz Wolfgang||Minimally invasive heart valve replacement|
|US20090062907 *||31 Aug 2007||5 Mar 2009||Quijano Rodolfo C||Self-expanding valve for the venous system|
|US20090198315 *||7 Jun 2007||6 Aug 2009||Younes Boudjemline||Vascular Stents, Methods of Use and Methods of Manufacture|
|1||Andersen. H.R. et al. "Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs." Euro. Heart J. (1992) 13:704-708.|
|2||Babaliaros, et al., "State of the Art Percutaneous Intervention for the Treatment of Valvular Heart Disease: A Review of the Current Technologies and Ongoing Research in the Field of Percutaneous Heart Valve Replacement and Repair," Cardiology 2007; 107:87-96.|
|3||Bailey, "Percutaneous Expandable Prosthetic Valves," In: Topol EJ, ed. Textbook of Interventional Cardiology. vol. 11. Second edition. WB Saunders, Philadelphia, 1994:1268-1276.|
|4||Block, et al., "Percutaneous Approaches to Valvular Heart Disease," Current Cardiology Reports, vol. 7 (2005) pp. 108-113.|
|5||Bonhoeffer, et al, "Percutaneous Insertion of the Pulmonary Valve," Journal of the American College of Cardiology (United States), May 15, 2002, pp. 1664-1669.|
|6||Bonhoeffer, et al, "Percutaneous Replacement of Pulmonary Valve in a Right-Ventricle to Pulmonary-Artery Prosthetic Conduit with Valve Dysfunction," Lancet (England), Oct. 21, 2000, pp. 1403-1405.|
|7||Bonhoeffer, et al, "Transcatheter Implantation of a Bovine Valve in Pulmonary Position: A Lamb Study," Circulation (United States), Aug. 15, 2000, pp. 813-816.|
|8||Boudjemline, et al, "Images in Cardiovascular Medicine. Percutaneous Aortic Valve Replacement in Animals," Circulation (United States), Mar. 16, 2004, 109, p. e161.|
|9||Boudjemline, et al, "Off-pump Replacement of the Pulmonary Valve in Large Right Ventricular Outflow Tracts: A Hybrid Approach," Journal of Thoracic and Cardiovascular Surgery (United States), Apr. 2005, pp. 831-837.|
|10||Boudjemline, et al, "Percutaneous Aortic Valve Replacement: Will We Get There?" Heart (British Cardiac Society) (England), Dec. 2001, pp. 705-706.|
|11||Boudjemline, et al, "Percutaneous Implantation of a Biological Valve in Aortic Position: Preliminary Results in a Sheep Study," European Heart Journal 22, Sep. 2001, p. 630.|
|12||Boudjemline, et al, "Percutaneous Implantation of a Biological Valve in the Aorta to Treat Aortic Valve Insufficiency-A Sheep Study," Medical Science Monitor-International Medical Journal of Experimental and Clinical Research (Poland), Apr. 2002, pp. BR113-BR116.|
|13||Boudjemline, et al, "Percutaneous Implantation of a Valve in the Descending Aorta in Lambs," European Heart Journal (England), Jul. 2002, pp. 1045-1049.|
|14||Boudjemline, et al, "Percutaneous Pulmonary Valve Replacement in a Large Right Ventricular Outflow Tract: An Experimental Study," Journal of the American College of Cardiology (United States), Mar. 17, 2004, pp. 1082-1087.|
|15||Boudjemline, et al, "Percutaneous Valve Insertion: A New Approach," Journal of Thoracic and Cardiovascular Surgery (United States), Mar. 2003, pp. 741-742.|
|16||Boudjemline, et al, "Stent Implantation Combined with a Valve Replacement to Treat Degenerated Right Ventricle to Pulmonary Artery Prosthetic Conduits," European Heart Journal 22, Sep. 2001, p. 355.|
|17||Boudjemline, et al, "Steps Toward Percutaneous Aortic Valve Replacement," Circulation (United States), Feb. 12, 2002, pp. 775-778.|
|18||Boudjemline, et al, "The Percutaneous Implantable Heart Valve," Progress in Pediatric Cardiology (Ireland), 2001, pp. 89-93.|
|19||Boudjemline, et al, "Transcatheter Reconstruction of the Right Heart," Cardiology in the Young (England), Jun. 2003, pp. 308-311.|
|20||Boudjemline, et al, "Percutaneous Implantation of a Biological Valve in the Aorta to Treat Aortic Valve Insufficiency—A Sheep Study," Medical Science Monitor—International Medical Journal of Experimental and Clinical Research (Poland), Apr. 2002, pp. BR113-BR116.|
|21||Boudjemline, et al. "Is Percutaneous Implantation of a Bovine Venous Valve in the Inferior Vena Cava a Reliable Technique to Treat Chronic Venous Insufficiency Syndrome?" Medical Science Monitor-International Medical Journal of Experimental and Clinical Research (Poland), Mar. 2004, pp. BR61-BR66.|
|22||Boudjemline, et al. "Is Percutaneous Implantation of a Bovine Venous Valve in the Inferior Vena Cava a Reliable Technique to Treat Chronic Venous Insufficiency Syndrome?" Medical Science Monitor—International Medical Journal of Experimental and Clinical Research (Poland), Mar. 2004, pp. BR61-BR66.|
|23||Coats, et al, "The Potential Impact of Percutaneous Pulmonary Valve Stent Implantation on Right Ventricular Outflow Tract Re-Intervention," European Journal of Cardio-Thoracic Surgery (England), Apr. 2005, pp. 536-543.|
|24||Cribier, A. et al, "Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis: First Human Case Description," Circulation (2002) 3006-3008.|
|25||Davidson et al., "Percutaneous therapies for valvular heart disease," Cardiovascular Pathology 15 (2006) 123-129.|
|26||Hanzel, et al., "Complications of percutaneous aortic valve replacement: experience with the Criber-Edwards(TM) percutaneous heart valve," Eurolntervention Supplements (2006), I (Supplement A) A3-A8.|
|27||Hanzel, et al., "Complications of percutaneous aortic valve replacement: experience with the Criber-Edwards™ percutaneous heart valve," Eurolntervention Supplements (2006), I (Supplement A) A3-A8.|
|28||Huber, et al., "Do Valved Stents Compromise Coronary Flow?" Eur. J. Cardiothorac. Surg. 2004;25:754-759.|
|29||Khambadkone, "Nonsurgical Pulmonary Valve Replacement: Why, When, and How?" Catheterization and Cardiovascular Interventions-Official Journal of the Society for Cardiac Angiography & Interventions (United States), Jul. 2004, pp. 401-408.|
|30||Khambadkone, "Nonsurgical Pulmonary Valve Replacement: Why, When, and How?" Catheterization and Cardiovascular Interventions—Official Journal of the Society for Cardiac Angiography & Interventions (United States), Jul. 2004, pp. 401-408.|
|31||Khambadkone, et al, "Percutaneous Implantation of Pulmonary Valves," Expert Review of Cardiovascular Therapy (England), Nov. 2003, pp. 541-548.|
|32||Khambadkone, et al, "Percutaneous Pulmonary Valve Implantation: Early and Medium Term Results," Circulation 108 (17 Supplement), Oct. 28, 2003, p. IV-375.|
|33||Khambadkone, et al. "Percutaneous Pulmonary Valve Implantation: Impact of Morphology on Case Selection," Circulation 108 (17 Supplement), Oct. 28, 2003, p. IV-642-IV-643.|
|34||Lutter, et al, "Percutaneous Aortic Valve Replacement: An Experimental Study. I. Studies on Implantation," The Journal of Thoracic and Cardiovascular Surgery, Apr. 2002, pp. 768-776.|
|35||Lutter, et al, "Percutaneous Valve Replacement: Current State and Future Prospects," Annals of Thoracic Surgery (Netherlands), Dec. 2004, pp. 2199-2206.|
|36||Ma, Ling., et al., "Double-crowned valved stents for off-pump mitral valve replacement," European Journal of Cardio Thoracic Surgery, 28:194-198, 2005.|
|37||Medtech Insight, "New Frontiers in Heart Valve Disease," vol. 7, No. 8 (2005).|
|38||Palacios, "Percutaneous Valve Replacement and Repair, Fiction or Reality?" Journal of American College of Cardiology, vol. 44, No. 8 (2004) pp. 1662-1663.|
|39||Pavcnik et al., "Aortic and venous valve for percutaneous insertion," Min. Invas. Ther. & Allied Techol. 2000, vol. 9, pp. 287-292.|
|40||Pelton et al., "Medical Uses of Nitinol," Materials Science Forum vols. 327-328, pp. 63-70 (2000).|
|41||Ruiz, "Transcathether Aortic Valve Implantation and Mitral Valve Repair: State of the Art," Pediatric Cardiology, vol. 26, No. 3 (2005).|
|42||Saliba, et al, "Treatment of Obstructions of Prosthetic Conduits by Percutaneous Implantation of Stents," Archives des Maldies du Coeur et des Vaisseaux (France), 1999, pp. 591-596.|
|43||Stassano et al., "Mid-term results of the valve-on-valve technique for bioprosthetic failure," Eur. J. Cardiothorac. Surg. 2000; 18:453-457.|
|44||Webb, et al., "Percutaneous Aortic Valve Implantation Retrograde from the Femoral Artery," Circulation (2006), 113;842-850.|
|Citing Patent||Filing date||Publication date||Applicant||Title|
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|US8524132||14 Apr 2011||3 Sep 2013||Abbott Cardiovascular Systems Inc.||Method of fabricating an intraluminal scaffold with an enlarged portion|
|US8673000 *||20 May 2011||18 Mar 2014||Medtronic, Inc.||Stents for prosthetic heart valves|
|US8840661 *||13 May 2009||23 Sep 2014||Sorin Group Italia S.R.L.||Atraumatic prosthetic heart valve prosthesis|
|US8920492||21 Aug 2013||30 Dec 2014||Sorin Group Italia S.R.L.||Cardiac valve prosthesis|
|US9078749||21 Aug 2014||14 Jul 2015||Georg Lutter||Truncated cone heart valve stent|
|US9095433||18 Oct 2011||4 Aug 2015||Georg Lutter||Truncated cone heart valve stent|
|US20090287296 *||13 May 2009||19 Nov 2009||Sorin Biomedica Cardio S.R.L.||Atraumatic prosthetic heart valve prosthesis|
|US20100100117 *||15 Oct 2009||22 Apr 2010||Obalon Therapeutics, Inc.||Intragastric device|
|US20110224780 *||15 Sep 2011||Charles Tabor||Stents for prosthetic heart valves|
|US20120046729 *||14 Apr 2011||23 Feb 2012||Abbott Vascular||Intraluminal scaffold having an enlarged portion|
|US20130166023 *||14 Jun 2011||27 Jun 2013||St. Jude Medical, Inc||Collapsible heart valve with angled frame|
|US20140142693 *||20 Nov 2012||22 May 2014||Medtronic, Inc||Valve Prosthesis Frames|
|U.S. Classification||623/2.17, 623/1.24|
|International Classification||A61F2/24, A61F2/06|
|Cooperative Classification||A61F2220/0075, A61F2250/0039, A61F2250/0018, A61F2/2436, A61F2250/003, A61F2/013, A61F2/07, A61F2/2433, A61F2230/0006, A61F2230/008, A61F2220/0091, A61F2/90, A61F2/89, A61F2/2418, A61F2230/0054, A61F2220/0058|
|European Classification||A61F2/01D, A61F2/07, A61F2/24D6|
|31 Jul 2009||AS||Assignment|
Owner name: MEDTRONIC, INC., MINNESOTA
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Owner name: MEDTRONIC, INC., MINNESOTA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:TABOR, CHARLES P.;EBERHARDT, CAROL E.;LASKE, TIMOTHY G.;AND OTHERS;SIGNING DATES FROM 20090629 TO 20090730;REEL/FRAME:023037/0706
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|5 Jan 2015||FPAY||Fee payment|
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